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REMS For Mavacamten Could Involve Additional Monitoring, BMS Says

User Fee Delayed; Potential For Systolic Dysfunction Needs Watching

Executive Summary

The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters. 

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BMS Does Not Think Pricing Or Monitoring Will Limit Camzyos Use

Bristol already is training cardiologists at major treatment centers in how to treat obstructive hypertrophic cardiomyopathy with Camzyos (mavacamten) based on the REMS in the US label. 

Cardiology Could Get A Jolt As FDA Reviews Novel Heart Failure Candidates From BMS, Cytokinetics

Upcoming US FDA decisions could bring breakthrough-designated approvals for BI/Lilly’s Jardiance in heart failure with preserved ejection fraction and BMS’ mavacamten in hypertrophic cardiomyopathy, while Cytokinetics bids to bring a new mechanism the busy heart failure with reduced ejection fraction space and earns a BTD in HCM.

Cytokinetics’ CK-274 Appears To Upstage BMS’s Newly Acquired Mavacamten

The REDWOOD-HCM study showed early, sustained efficacy and no serious adverse events with a drug Cytokinetics designed to be superior to mavacamten, a drug it spun out via BMS-acquired MyoKardia.

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